NCT04630054

Brief Summary

The primary goal of the village-level intervention is to assess whether mask-wearing reduces community-level COVID-19 seroconversion. The individual experiment assess whether masks protect against COVID-19 seroconversion. It also assesses the efficacy of high-quality cloth vs. surgical masks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350,000

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

November 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

November 13, 2020

Last Update Submit

January 12, 2022

Conditions

Covid19

Keywords

MasksTransmissionSeroprevalenceBangladesh

Outcome Measures

Primary Outcomes (1)

  • Symptomatic SARS-CoV2 infection

    Symptomatic SARS-CoV2 infection, assessed via antibody testing 12 weeks after baseline, among individuals who report symptoms consistent with COVID-19 at 5 weeks or 9 weeks after baseline

    12 weeks

Secondary Outcomes (3)

  • SARS-CoV2 infection

    12 weeks

  • Observed prevalence of proper mask wearing

    intervention weeks 0, 1, 2, 4, 6, 8, and 12 in the community experiment and intervention weeks 0, 1, 2, 4, and 6 in the individual experiment

  • Respiratory infection prevalence

    5 and 9 weeks

Study Arms (2)

Mask Intervention

EXPERIMENTAL

Communities and individuals randomized to the intervention arm will be given masks and behavior change communication to motivate proper mask use. In the community experiment, every adult in communities randomized to the intervention arm will be encouraged to wear a mask when outside their housing compound and around other people. In the individual experiment, individuals randomized to the intervention arm will not be asked to recommend masks to others, but will also not be discouraged from recommending mask use to others.

Device: Face maskBehavioral: Face mask awareness

Control

NO INTERVENTION

Control individuals will receive no masks or behavior change communication.

Interventions

Face maskDEVICE

Intervention individuals will be given cloth or surgical face masks.

Mask Intervention
Face mask awarenessBEHAVIORAL

Intervention individuals will be told about the importance of wearing face masks that cover the nose, mouth, and chin. Mask by mask promoters and community and religious leaders will encourage mask wearing.

Mask Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community experiment: Live in selected village
  • Individual experiment: Work in selected market

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action

Dhaka, 1213, Bangladesh

Location

Related Publications (2)

  • Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.

    PMID: 38597249DERIVED

  • Abaluck J, Kwong LH, Styczynski A, Haque A, Kabir MA, Bates-Jefferys E, Crawford E, Benjamin-Chung J, Raihan S, Rahman S, Benhachmi S, Bintee NZ, Winch PJ, Hossain M, Reza HM, Jaber AA, Momen SG, Rahman A, Banti FL, Huq TS, Luby SP, Mobarak AM. Impact of community masking on COVID-19: A cluster-randomized trial in Bangladesh. Science. 2022 Jan 14;375(6577):eabi9069. doi: 10.1126/science.abi9069. Epub 2022 Jan 14.

    PMID: 34855513DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Masks

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The intervention involves wearing a face mask so participants will know if they are in the intervention group. The investigators will be blinded as to intervention assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 16, 2020

Study Start

November 15, 2020

Primary Completion

June 29, 2021

Study Completion

June 29, 2021

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

We do not plan to share individual participant data with other researchers

Locations

BA(1)